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Quality Engineer Medical Device Jobs in Colorado

Sr Quality Design Engineer

Westminster, CO ยท On-site

$89K - $121K/yr

Sr Quality Design Engineer Principal Duties and Responsibilities: โ€ข Serves as the design quality ... EU medical device regulations, design assurance, risk analysis techniques, and product testing ...

Sr Design Quality Engineer

Lafayette, CO ยท On-site

$92K - $124K/yr

The Senior Design Quality Engineer plays a critical role in applying Design Controls, Risk ... Experience in the medical device industry or in a regulated industry with similar quality and ...

Sr Design Quality Engineer

Lafayette, CO ยท On-site

$92K - $124K/yr

The Senior Design Quality Engineer plays a critical role in applying Design Controls, Risk ... Experience in the medical device industry or in a regulated industry with similar quality and ...

Sr Design Quality Engineer

Lafayette, CO ยท On-site

$92K - $124K/yr

The Senior Design Quality Engineer plays a critical role in applying Design Controls, Risk ... Experience in the medical device industry or in a regulated industry with similar quality and ...

Prin Quality Engineer

Lafayette, CO ยท On-site

$75K - $96K/yr

Medical device industry. * Technical Skills: Proficient in quality management systems, risk ... to engineer the extraordinary. For Baccalaureate degrees earned outside of the United States, a ...

Prin Quality Engineer

Lafayette, CO ยท On-site

$75K - $96K/yr

Medical device industry. * Technical Skills: Proficient in quality management systems, risk ... to engineer the extraordinary. For Baccalaureate degrees earned outside of the United States, a ...

Prin Quality Engineer

Lafayette, CO ยท On-site

$75K - $96K/yr

Medical device industry. * Technical Skills: Proficient in quality management systems, risk ... to engineer the extraordinary. For Baccalaureate degrees earned outside of the United States, a ...

... stringent regulatory and quality standards in a regulated medical device environment ... Provide engineering production support for existing medical diagnostic product lines.

Sr Quality Engineer

Lafayette, CO ยท On-site

$92K - $124K/yr

Medical device industry. * Technical Skills: Proficient in quality management systems, risk ... to engineer the extraordinary. For Baccalaureate degrees earned outside of the United States, a ...

Sr Quality Engineer

Lafayette, CO ยท On-site

$92K - $124K/yr

Medical device industry. * Technical Skills: Proficient in quality management systems, risk ... to engineer the extraordinary. For Baccalaureate degrees earned outside of the United States, a ...

Sr Quality Engineer

Lafayette, CO ยท On-site

$92K - $124K/yr

Medical device industry. * Technical Skills: Proficient in quality management systems, risk ... to engineer the extraordinary. For Baccalaureate degrees earned outside of the United States, a ...

... stringent regulatory and quality standards in a regulated medical device environment ... Provide engineering production support for existing medical diagnostic product lines.

Senior Quality Engineer

Golden, CO ยท On-site

$95K - $140K/yr

This role blends hands-on quality engineering with strategic quality leadership. Examples include ... Working knowledge of US medical device regulations, including ISO 13485 and CFR 820. * Strong ...

Senior Quality Engineer

Golden, CO ยท On-site

$95K - $140K/yr

This role blends hands-on quality engineering with strategic quality leadership. Examples include ... Working knowledge of US medical device regulations, including ISO 13485 and CFR 820. * Strong ...

Quality Engineer

Fort Collins, CO ยท On-site

$71K - $91K/yr

... medical device industry to every project. Our employees are important to us! We want the best for ... Serve as a Quality Engineering liaison for internal and external customers, supporting quality ...

Quality Engineer

Fort Collins, CO ยท On-site

$75K - $110K/yr

... medical device industry to every project. Our employees are important to us! We want the best for ... Serve as a Quality Engineering liaison for internal and external customers, supporting quality ...

Showing results 21-40

Quality Engineer Medical Device information

See Colorado salary details

$22

$38

$74

How much do quality engineer medical device jobs pay per hour?

As of Sep 7, 2026, the average hourly pay for quality engineer medical device in Colorado is $38.61, according to ZipRecruiter salary data. Most workers in this role earn between $26.06 and $48.27 per hour, depending on experience, location, and employer.

What does a quality engineer do in the medical device industry?

A Quality Engineer in the medical device industry is responsible for ensuring that medical devices meet all regulatory standards and quality requirements. They develop and implement quality assurance processes, perform risk assessments, and conduct inspections and audits to make sure products are safe and effective. Quality Engineers also collaborate with design, manufacturing, and regulatory teams to resolve quality issues and improve product reliability. Their work is crucial for maintaining compliance with standards such as ISO 13485 and FDA regulations.

What are the key skills and qualifications needed to thrive as a quality engineer in the medical device industry?

To thrive as a Quality Engineer in the medical device industry, you need a strong background in quality assurance, regulatory compliance (such as ISO 13485 and FDA 21 CFR Part 820), and engineering principles, often supported by a relevant engineering degree. Familiarity with quality management systems (QMS), risk analysis tools (like FMEA), and certifications such as CQE (Certified Quality Engineer) are typically required. Attention to detail, problem-solving, and effective communication are critical soft skills for collaborating with cross-functional teams and ensuring product safety. These skills and qualifications are vital to maintain regulatory compliance, uphold product quality, and protect patient safety in a highly regulated environment.

How does a quality engineer in the medical device industry typically collaborate with cross-functional teams to ensure product compliance?

Quality Engineers in the medical device sector work closely with cross-functional teams such as design, manufacturing, regulatory affairs, and supply chain. They participate in design reviews, risk assessments, and process validations to ensure that products meet both internal quality standards and external regulatory requirements (such as FDA or ISO 13485). Regular collaboration involves reviewing documentation, addressing non-conformances, and implementing corrective actions. This teamwork is critical to proactively identify potential issues and maintain continuous product quality throughout the development and production lifecycle.

What is the difference between Quality Engineer Medical Device vs Quality Assurance Specialist Medical Device?

AspectQuality Engineer Medical DeviceQuality Assurance Specialist Medical Device
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, Six Sigma, ASQ certifications
Work EnvironmentDesign, development, manufacturing, and process improvementAuditing, compliance, documentation, and process verification
Employer & Industry UsageMedical device manufacturers, R&D labsMedical device companies, regulatory agencies, consulting firms

While both roles focus on quality in the medical device industry, a Quality Engineer Medical Device primarily works on product design, process development, and continuous improvement. In contrast, a Quality Assurance Specialist Medical Device emphasizes compliance, auditing, and ensuring adherence to regulatory standards. Both roles are essential for maintaining product safety and quality, but they differ in scope and daily responsibilities.

What are the most commonly searched types of Quality Engineer Medical Device jobs in Colorado?

The most popular types of Quality Engineer Medical Device jobs in Colorado are:

What are popular job titles related to Quality Engineer Medical Device jobs in Colorado?

For Quality Engineer Medical Device jobs in Colorado, the most frequently searched job titles are:

What job categories do people searching Quality Engineer Medical Device jobs in Colorado look for?

The top searched job categories for Quality Engineer Medical Device jobs in Colorado are:

What cities in Colorado are hiring for Quality Engineer Medical Device jobs?

Cities in Colorado with the most Quality Engineer Medical Device job openings:

Infographic showing various Quality Engineer Medical Device job openings in Colorado as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, 1% Temporary, and 6% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $80,319 per year, or $38.6 per hour.

Firmware Engineer - Medical Devices

TERUMO BCT, INC

Lakewood, CO โ€ข On-site

$100 - $125/hr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 2 days ago


Job description

Firmware Engineer - Medical Devices

Date: Aug 5, 2026

Location: Lakewood, CO, US

At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patientโ€™s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

The firmware this engineer writes runs inside medical devices used to care for patients around the world, so it has to work correctly and safely. This is handsโ€‘on work close to the silicon: bringing up new boards, writing the lowโ€‘level drivers, and building the realโ€‘time control systems that make the hardware do its job. The engineer carries firmware from the first board bringโ€‘up through to a maintainable, productionโ€‘ready product.

The role spans the firmware stack: embedded Linux on NXP i.MX processors and lowโ€‘level firmware on the NXP ARM Cortexโ€‘M4 microcontrollers used in current TBCT designs. The Firmware Engineer delivers firmware for products in the field today and helps advance future platform generations built around more capable processors and emerging onโ€‘chip technologies. The firmware produced in this role directly shapes device reliability, performance, and compliance with medical device quality and regulatory standards.

Collaboration is central to the role. The Firmware Engineer works closely with Electrical Engineering, Systems Engineering, Software, DevOps, and Quality to bring up new hardware, integrate firmware into the larger system, and turn product requirements into testable, verifiable firmware that performs dependably in the field.

ESSENTIAL DUTIES
  • Own board bringโ€‘up on new and revised hardware, verifying power sequencing, clocks, memory, and peripherals on the first boards and working with Electrical Engineering to contribute to architecture/schematic reviews, board bringโ€‘up, and resolving hardware and firmware issues.
  • Write, port, and debug device drivers and lowโ€‘level interfaces (I2C, SPI, UART, USB, GPIO, ADC/DAC, PWM, DMA) for onโ€‘board sensors, actuators, and communication peripherals.
  • Develop firmware for the control systems that operate physical hardware such as motors, valves, pumps, and heaters, including realโ€‘time, timingโ€‘sensitive control loops.
  • Develop and maintain the embedded Linux stack on NXP i.MX platforms, including board support packages, device trees, kernel configuration, operating system integration, and userspace services, within a Yocto build environment.
  • Help evaluate and choose microcontroller architectures for future platforms, including parts with advanced onโ€‘chip processing capabilities, by building prototypes, benchmarking performance and power, and writing up the tradeโ€‘offs.
  • Optimize firmware for speed, memory footprint, and power on resourceโ€‘constrained targets.
  • Develop and maintain bootloaders, secure boot, and firmware update paths so devices start reliably and stay current in the field.
  • Translate system and product requirements into firmware designs, and produce the design documentation required by regulatory and quality processes (IEC 62304, ISO 14971, ISO 13485).
  • Plan and execute firmware verification and validation, and resolve issues found in development, integration, and the field. Create and execute automated unit tests, integration tests, and hardwareโ€‘inโ€‘theโ€‘loop (HIL) testing.
  • Participate in and lead code and design reviews, and mentor engineers earlier in their careers.
  • Participate in software risk assessments, hazard analyses, SWFMEA and implement cybersecurity principles for connected devices
  • Partner with Systems, Electrical, Mechanical, and Quality Engineering across the full product lifecycle, from first prototype through production.
OTHER DUTIES AND RESPONSIBILITIES
  • Help improve firmware development and test processes so they meet industry standards and internal benchmarks, and support inspection readiness with clear documentation and traceability.
  • Keep firmware maintainable, reusable, and scalable so it integrates cleanly across projects and platforms.
  • Stay current with embedded tools, techniques, and security practices, and bring useful improvements back to the team.
MINIMUM QUALIFICATION REQUIREMENTSEducation

Bachelorโ€™s degree in Computer Engineering, Electrical Engineering, Computer Science, or a related field, or an equivalent combination of education and experience sufficient to successfully perform the essential functions of the job.

Experience

Minimum 4 years of experience developing embedded firmware for hardware products, including handsโ€‘on board bringโ€‘up and hardware debugging carried through to a shipped product. Experience in a regulated industry (medical, automotive, or aerospace) is preferred.

Skills
  • Strong proficiency in C/C++ on resourceโ€‘constrained embedded targets.
  • Handsโ€‘on microcontroller and SoC development on ARMโ€‘based architectures, such as NXP i.MX processors and ARM Cortexโ€‘M4 microcontrollers.
  • Board bringโ€‘up and hardware debugging with oscilloscopes, logic analyzers, and JTAG/SWD debuggers.
  • Solid command of lowโ€‘level I/O and serial protocols (I2C, SPI, UART, USB, GPIO).
  • Working knowledge of embedded Linux internals, including the kernel, device drivers, device trees, and board support packages, and/or realโ€‘time and bareโ€‘metal firmware.
  • Experience with a Yocto build environment; Buildroot or PetaLinux also applicable.
  • Ability to read schematics and datasheets and determine whether an issue is rooted in hardware, firmware, or software.
  • Proficient in source code management and CI workflows (e.g., Git and GitLab), with scripting in Python or Bash.
  • Familiarity with wired and wireless connectivity, including TCP/IP, Wiโ€‘Fi, Bluetooth/BLE, and 5G.
  • Familiarity with medical device standards and lifecycle processes (IEC 62304, ISO 14971, ISO 13485, IEC 60601) is preferred.
  • Experience ordemonstratedability to work in middleware and userโ€‘space components, including interprocess communication, service design, and systemโ€‘level integration on embedded Linux is preferred.
  • Clear communication and disciplined documentation habits, which matter in a regulated environment.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

LOCATION

Hybrid position reporting to the Lakewood, CO headquarters a minimum of 3 days a week.

PHYSICAL REQUIREMENTS
  • Typical Office Environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
  • The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range: $109,800.00to$137,200.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base: 7.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, workโ€‘life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for workโ€‘life balance we have vacation and sick time programs for associates. For us, itโ€™s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

  • Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
  • In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue.
  • We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
  • We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
  • Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
    • Respect โ€“ Appreciative of others
    • Integrity โ€“ Guided by our mission
    • Care โ€“ Empathetic to patients
    • Quality โ€“ Committed to excellence
    • Creativity โ€“ Striving for innovation
  • We contribute to the Leukemia and Lymphoma Society (LLS), raising $2.4 million USD since 2025.

We are proud to be an Equal Opportunity Affโ€ฆ

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobaccoโ€‘free workplaces, and we maintain a drugโ€‘free workplace and perform preโ€‘employment substance abuse testing and detailed background verification.

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